A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy in the Definitive Treatment of Head-and-Neck Cancer
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy in the Definitive Treatment of Head-and-Neck Cancer
In this study, we will plan additional measurements of the position of the patient's organs
weekly during radiation treatment. We will analyze these measurements in order to evaluate
whether we need to adjust our treatment procedures for the remainder of the treatments. We
might adjust the dose of radiation received to specific organs in order to try to minimize
the amount of radiation the healthy tissue receives.
Inclusion Criteria:
- Age >= 18
- Karnofsky Performance Status of >= 60
- New diagnosis of head-and-neck cancer, all subsites included (i.e. nasopharynx,
oropharynx, oral cavity, hypopharynx, larynx.)
- All stages with measurable gross disease (>= 1.0 cm) by CT imaging
- Pathologic confirmation of squamous cell carcinoma by biopsy or cytology
- Signed study-specific consent form
- Sequential or concurrent chemotherapy is allowed but not mandated. (no chemotherapy
is allowed if patient is judged not to be a candidate for chemotherapy by the medical
oncologist)
Exclusion Criteria
- Age < 18
- Karnofsky Performance Status < 60
- Radiographic or pathologic evidence of distant metastatic disease (i.e. other than
cervical lymph nodes)
- Prior radiation therapy to the head-and-neck region
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility of adaptive radiation therapy in the definitive treatment (MLC-based IMRT or helical tomotherapy)
Outcome Description:
Feasibility is determined by employing weekly 3D onboard imaging for plan re-evaluation and initiation of an adaptive process if the original PTV and/or normal structure goals are compromised.
Outcome Time Frame:
7 weeks
Safety Issue:
Yes
Principal Investigator
Wade Thorstad, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Washington University School of Medicine
Authority:
United States: Institutional Review Board
Study ID:
06-1210
NCT ID:
NCT00608751
Start Date:
January 2007
Completion Date:
January 2008
Related Keywords:
- Head and Neck Cancer
- Newly Diagnosed head and neck cancer
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
